Phase 3 N=210 Rifaximin for Prevention of Travellers' Diarrhea
Diarrhea
Primary: Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment — 15; 48 Participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=120 Traveler's Diarrhea (TD) Automated Process
Prevention of Travelers' Diarrhea
Primary: Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo — 432.6; 400.5; 4477.5; 490.6 geometric mean titer
Phase 3 N=264 Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)
Traveler's Diarrhea
Primary: Time to Last Unformed Stool (TLUS) — 37.4; 21.; 68; 46 TLUS (hours)
Phase 2 N=600 Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Diarrhea
Primary: Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs…
Phase 1 N=27 CampETEC Hyperimmune Bovine Colostrum (HBC)
Healthy Volunteer
Primary: Incidence of Adverse Events — 1; 1; 0; 1 events
Phase 3 N=835 Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Traveler's Diarrhea
Primary: Time to Last Unformed Stool (TLUS) — 44.3; 40.3 hours
Phase 3 N=30 Efficacy of Rifaximin in Preventing Campylobacteriosis
Dysentery · Diarrhea · Enteric Campylobacteriosis
Primary: Campylobacteriosis — 13; 11 Participants
Early Phase 1 N=66 Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
Antibiotic-associated Diarrhea
Primary: Level of Fecal Short-chain Fatty Acid (SCFA) Acetate — 53.1; 45.2; 42.3; 38.1 micromolar (μM)
N/A N=214 Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotics Associated Colitis · Pulmonary Infection
Primary: Presence of AAD — 12 participants — p=<0.05
Phase 1 N=60 Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Healthy Volunteer
Primary: Safety of Serum Derived Bovine Immunoglobulins (BSIgG) — 1; 2; 0; 2 Participants
Phase 3 N=739 Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
Diarrhea
Primary: Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population — 90; 93…
Early Phase 1 N=118 Mechanisms of Probiotics and Antibiotic-Associated Diarrhea
Antibiotic-associated Diarrhea
Primary: Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate) — 23.55; -13.9; -19.5; 7.25 micromolar
Phase 2 N=60 Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
Diarrhea
Primary: Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal — 0; 0; 0; 0 adverse events
Phase 2 N=53 Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients
Breast Cancer
Primary: Diarrhea for >= 2 Consecutive Days — 68; 69.6; 65.2; 72.2 percentage of patients
Phase 2 N=150 Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
Cholera
Primary: Stool Output Volume During Treatment Period. — 9.82; 9.31; 5.69; 7.29 ml/kg·h-1 — p=0.003
N/A N=71 Oral Zinc for the Treatment of Acute Diarrhea in US Children
Diarrhea · Gastroenteritis
Primary: Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo. — 73; 72; 48; 76.8 Hours — p=0.88
Phase 4 N=674 Screening to Prophylax Against Clostridium Difficile Infection -
Clostridium Difficile Infection
Primary: The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. — 0; 0…
Phase 4 N=51 Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Clostridium Difficile Infection · Prophylaxis · Vancomycin
Primary: Clostridium Difficile Infection Occurrence — 2; 0 Participants
Phase 4 N=620 Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Immunity to Oral Rotavirus Vaccine · Immunity to Oral Polio Vaccine · Shedding of Oral Rotavirus Vaccine
Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants
Phase 3 N=437 Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
Diarrhea · Clostridium Infections
Primary: The Incidence of Antibiotic-associated Diarrhea. — 216; 221 participants
Phase 3 N=255 Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Antibiotic-Associated Diarrhea · Clostridium Difficile-Associated Diarrhea
Primary: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. — 84; 85; 86 participants — p==0.02
Phase 3 N=197 Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera
Cholera
Primary: % of Participants With Moderate to Severe Diarrhea — 5.7; 59.1 percentage of participants
Phase 1 N=57 Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
Escherichia Coli Infection
Primary: Safety - Occurrence of Adverse Events — 7; 21; 19; 20 Number of Adverse Events
Phase 4 N=88 Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Diarrhea
Primary: Duration of Diarrhea — 2; 2 days — p=0.43
Phase 2 N=79 Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Recurrent Clostridium Difficile Infection · Clostridium Difficile Infection · CDI
Primary: Recurrent Clostridium Difficile Infection (CDI) — 17; 24 Participants — p=0.22
Phase 3 N=396 Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea
Diarrhea · Cholera
Primary: Stool Output — 4769; 4742; 1688; 1704 gram — p=0.9941
Phase 3 N=520 Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
Antibiotic-associated Diarrhea
Primary: Number of Participants With the Occurrence of Antibiotic-associated Diarrhea (AAD) - Per Protocol (PP) Population — 4; 17 Participants — p=0.007
Phase 2 N=47 Cholera Anti-Secretory Treatment Trial
Cholera
Primary: Diarrheal Stool Output Rate — 25.42; 32.57 mL/hour — p=0.2254
Phase 4 N=130 Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing
Prophylaxis of Acute Mountain Sickness
Primary: Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score — 21; 21 Participants
Phase 1 N=48 Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea
Campylobacter Infection
Primary: Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events) — 10; 17; 10; 29 Adverse Events